Isotretinoin 5mg capsules (once daily) in the treatment of persistent low grade adult acne.
- Conditions
- Persistent low grade adult acne.Skin - Dermatological conditions
- Registration Number
- ACTRN12612000062820
- Lead Sponsor
- Douglas Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Male or female aged between 25 and 55 years at the time of randomization.
If the participant is female, she should be either: post menopausal for at least 1 year, surgically sterile for at least 3 months, stable on hormonal contraceptives for at least 6 months and agree to continue these during the study and for 30 days after treatment completion, or be willing to use double-barrier contraception for the duration of the study and for 30 days after treatment completion.
Two or more acne lesions/month for at least the last 3 months as reported by the participant and evident at the time of consultation.
BMI between 19 and 35.
Provide signed and dated written informed consent.
Be willing and able to comply with the requirements of the study including taking study medication as directed.
Less than two acne lesions /month.
Acne of Grade 2 or more on the Modified Leeds Acne Assessment Scale.
Participants with 10 or more macro comedones.
Concomitant drug therapy with Vitamin A or its derivatives, tetracyclines, keratolytic or exfoliative antiacne treatments, carbamazepine, spironolactone, azelaic acid, St. Johns Wort or preparations containing St. Johns Wort.
Participants who have received any antibiotic treatment within the 3 months preceding the start of the study.
Participants who have used topical retinoids in the month preceding the start of the study (participants using cosmetics that include low dose topical retinoids will not be excluded).
Females receiving estrogen and/or progesterone treatment, unless on a stable dose for at least 6 months preceding the start of the study and still with persistent acne. If females are using Mirena it must have been in place for at least 6 months preceding the start of the study.
Participants receiving glucocorticoid treatment within one month preceding the start of the study (except for inhaled corticosteroids for asthma where the dose should be stable throughout the study and not exceed 1 mg/day).
Participants who have received treatment with isotretinoin within 6 months of the commencement of the study.
Participants with a known or reported history of Hypervitaminosis A, depression, psychoses, cardiovascular disease, renal disease, lipid disorders, epilepsy, glaucoma, cataract, hepatic disease, diabetes, pancreatitis, blood disorders including anaemia, recurrent migraine headaches, dry eye syndrome or any other condition in the opinion of the investigator that would compromise the safety of the participant or confound the study endpoints. Any participant with a serious or unstable concurrent disease will be excluded from the study.
Participants who are found to have elevated triglyceride levels or abnormal liver function assessed as clinically significant by the Investigator at the screening blood test.
Participants with a history of alcohol abuse or drug addiction.
Participants who are known to be Hepatitis A, B or C or HIV positive at the time of screening.
Participants who have participated in another drug study in the 60 days preceding the start of the study.
Participants who are sensitive to isotretinoin and other vitamin A derivatives or are severely allergic to other substances.
Female participants who are pregnant or who are planning to become pregnant during the course of the study. Female participants must agree to adhere to the study requirement in relation to contraception.
Females who are breastfeeding.
Participants who do not agree to NOT donate blood for two months after the completion of the study.
Participants, who do not, according to the Investigator, understand the information and procedures of the study, in particular the study restrictions and risks involved.
Participants who are unable to conform to the requirements of the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of isotretinoin 5mg daily compared to placebo in persistent low grade adult acne. The Investigator will perform a clinical assessment of the acne lesion count at week 16, adjusted for the acne lesion count at day 0.[Over 16 weeks]
- Secondary Outcome Measures
Name Time Method